A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy (SEER-2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 36
- 主要终点
- Percentage of subjects achieving complete healing of PED at Day 29
研究概览
简要总结
The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)
详细描述
Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of partial or total impairment of trigeminal innervation. The resulting loss of corneal sensitivity (anesthesia) leads to a reduction in lacrimation and a decline in status, metabolism, and mitosis of corneal epithelial cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
0.1% RGN-259 Opthalmic Solution
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days
干预措施: RGN-259 (Drug)
Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution)
It is composed of the same excipients as RGN-259 but does not contain Tβ4
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects achieving complete healing of PED at Day 29
时间窗: Day 29
Percentage of subjects achieving complete healing of the Persistent Epithelial Defect (PED) at Day 29 determined by corneal fluorescein staining as measured by the Central Reading Center.
次要结局
- Visual Acuity determined by ETDRS(Day 8, 15, 22, 29, 36, and 43)
- NK stage by Mackie classification(Day 8, 15, 22, 29, 36, and 43)
- Corneal sensitivity inside the lesion determined by Cochet Bonnet aesthesiometer (Unit: mm)(Day 8, 15, 22, 29, 36, and 43)
- Percentage of subjects achieving complete healing of PED at Day 29(Day 29)
- Percentage change from baseline of lesion size(Day 8, 15, 22, 29, 36, and 43)